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Pharmaceutical process validation / edited by Robert A. Nash, Alfred H. Wachter.

Contributor(s): Berry, Ira R, 1942- | Nash, Robert A, 1930-.
Material type: TextTextSeries: Drugs and the pharmaceutical sciences: Publisher: New York : Marcel Dekker, c2003Edition: International 3rd ed., rev. and expanded.Description: xxxvi, 860 p. : ill. ; 24 cm.ISBN: 0824708385 (alk. paper); 9780824708382.Subject(s): Pharmaceutical industry -- Quality control | Drugs -- Standards -- United States | Drug Evaluation -- standards -- United States | Drug Industry -- standards -- United States | Quality ControlDDC classification: 615.1 Online resources: Publisher description | WorldCat details | E-Book Fulltext
Contents:
Table of contents Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols -- Process validation of phamaceutical ingredients -- Qualification of water and air handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic proess validation -- Harmonization GMPs, and validation.
Summary: The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends
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Non-fiction 615.1 PHA 2003 (Browse shelf) Not for loan
Text Text EWU Library
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Non-fiction 615.1 PHA 2003 (Browse shelf) C-1 Not For Loan 16427
Text Text EWU Library
Reserve Section
Non-fiction 615.1 PHA 2003 (Browse shelf) C-2 Not For Loan 16428
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Includes bibliographical references and index.

Table of contents Regulatory basis for process validation --
Prospective process validation --
Retrospective validation --
Sterilization validation --
Validation of solid dosage forms --
Validation for medical devices --
Validation of biotechnology processes --
Transdermal process validation --
Validation of lyophilization --
Validation of inhalation aerosols --
Process validation of phamaceutical ingredients --
Qualification of water and air handling systems --
Equipment and facility qualification --
Validation and verification of cleaning processes --
Validation of analytical methods and processes --
Computer system validation: controlling the manufacturing process --
Integrated packaging validation --
Analysis of retrospective production data using quality control charts --
Statistical methods for uniformity and dissolution testing --
Change control and SUPAC --
Process validation and quality assurance --
Validation in contract manufacturing --
Terminology of nonaseptic proess validation --
Harmonization GMPs, and validation.

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends

Pharmacy

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